IPSEN

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) today announced the presentation of 13 new abstracts ¹ during the 17 th European Neuroendocrine Tumor Society (ENETS) Annual Conference, taking place virtually worldwide, (March 11-13, 2020) and the simultaneous publication of the PRESTO study in the medical journal, Advances in Therapy . ² These data reinforce Ipsen’s personal approach to working with patients living with neuroendocrine tumors (NETs) and acromegaly, and healthcare professionals treating these conditions.

NETs are rare tumors, but incidences are increasing,³ partly due to improvements in diagnosis and increased awareness⁴ . NETs and the symptoms associated with them have a substantial negative impact on patients’ overall health, quality of life and work life.

Acromegaly is a rare, chronic pituitary hormonal disorder with physical, neuropsychiatric and neurocognitive symptoms. Due to the insidious onset, slow progression and lack of awareness of the disease, acromegaly often takes 5–10 years to diagnose. Diagnostic delays can lead to an increased number and more severe symptoms and comorbidities that can become difficult to manage, reduce the quality of life and increase the risk of mortality.⁵

Among the results to be showcased by Ipsen during ENETS 2020, several studies featured the Somatuline^® Autogel^® (lanreotide autogel) new syringe. Alongside PRESTO, these included a patient and nurse satisfaction appraisal of use related to the Somatuline^® Autogel^® new syringe compared with the previous syringe (SONATE), an evaluation of patient satisfaction with the new syringe when self-injecting (AUTOSOMA) and more broadly, novel perspectives on healthcare professional preferences for different somatostatin analogs in the management of NETs and acromegaly.

Amauri Soares, Vice-President, Medical Affairs Oncology at Ipsen commented: “Transforming the lives of patients living with debilitating conditions such as NETs and acromegaly requires a joined-up, co-creating approach and the Somatuline^® Autogel^® new syringe was developed based on feedback from physicians, nurses, caregivers and patients who use these delivery systems every day. So, we are proud to be sharing new data during ENETS that demonstrates our commitment beyond clinical studies to uncover patient and nurse preferences, and to better understand patient treatment administration needs whether in hospital or at home. Ultimately, we are committed to ensuring these insights will continue to help us address the high unmet needs of these patients living with rare diseases.”

Among the Ipsen data to be showcased during ENETS 2020, key presentations include:

• PRESTO: Evaluation of Nurse Preferences Between the Lanreotide Autogel (LAN) New Syringe and Octreotide Long-Acting Release (LAR) Current Syringe: An International Simulated Use Study
• Patient and Healthcare Practitioner Perspectives of Somatostatin Analogs in the Management of Neuroendocrine Tumors and Acromegaly: A Systematic Literature Review (SLR)
• SONATE : Patient and nurse satisfaction with the new Lanreotide Autogelpre-filled syringe in neuroendocrine tumors: a prospective study (France)
• AUTOSOMA: Development and initial validation of a brief questionnaire to assess patient satisfaction with self-injection of Lanreotide Autogel: Results during a home training programme (Spain)
• EXPLAIN: Evaluating the use of Plasma Proteins to Predict Progressive Disease in Patients with Small Intestinal Neuroendocrine Tumours

Ipsen also announced the parallel publication of the multinational, simulated-use PRESTO study in the peer-reviewed medical journal, Advances in Therapy .² The PRESTO study design included the international recruitment of nurses experienced in performing injections in patients with NETs and/or acromegaly, which limited a center or country effect.

The study questionnaire was carefully designed through a systematic literature search and developed with input from end users (nurses/patients) and an expert in patient-reported outcomes to ensure consistency with real-life decision-making. Nurses participating in the PRESTO study rated and ranked the importance of nine attributes for the Somatuline^® Autogel^® new syringe and the Octreotide LAR current syringe.

“The experiences, attitudes and knowledge of both patients and healthcare practitioners such as nurses are essential for meaningful progress in complex disease management,” said Daphne T Adelman, Clinical Nurse Specialist from Northwestern University in Chicago, U.S. and a lead author on the PRESTO study. “In the absence of head-to-head clinical trials, these data give healthcare professionals important and meaningful insights for the optimal management of patients. The ENETS poster presentation and the Advances in Therapy publication for the PRESTO study further validate the new syringe design enhancements and have broader implications for optimizing patients’ treatment experience.”

Overview of Ipsen presentations featuring Somatuline^® Autogel^® (lanreotide autogel) during the ENETS 2020 Annual Conference:¹

Abstract title	Poster number
Evaluation of Nurse Preferences Between the Lanreotide Autogel New Syringe and Octreotide Long-Acting Release Syringe: An International Simulated Use Study (PRESTO)	H29
Quality of Life, Tumour Heterogeneity and Biomarker Levels in Patients with Progressive Pancreatic or Midgut Neuroendocrine Tumours: Baseline Data from CLARINET FORTE	H25
Patient and Healthcare Practitioner Perspectives of Somatostatin Analogs in the Management of Neuroendocrine Tumors and Acromegaly: A Systematic Literature Review	H13
OPERA: O bservational study of P erception of information and quality of life in patients with gastroE nteropancreatic neuR oendocrine tumors starting lA nreotide autogel – Baseline characteristics	D23
Patient and nurse satisfaction with the new lanreotide autogel pre-filled syringe in neuroendocrine tumors (NET): a prospective study (SONATE)	H30
Effectiveness of Lanreotide 120 mg (LAN) in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (panNET) in Routine Clinical Practice	P09
Development and initial validation of a brief questionnaire to assess patient satisfaction with self-injection of lanreotide autogel: Results during a home training programme (AUTOSOMA)	H16
Somatostatin analogs: the economic value of lanreotide autogel delivery attributes in the treatment of GEP-NET versus octreotide LAR – a UK budget impact analysis	H14
Lanreotide autogel and octreotide LAR treatment patterns: results from a nationwide French retrospective study	H12
Longitudinal Changes in Plasma 5-hydroxyindoleacetic Acid (5-HIAA) and Other Biomarkers during Treatment of Functional Midgut Neuroendocrine Tumours (NETs) with Lanreotide Autogel: CALM NET Study Results	F22
Use of Plasma Proteins to Predict Progressive Disease in Patients with Small Intestinal Neuroendocrine Tumours - The Nordic NET Biomarker Group (EXPLAIN)	F12 Oral presentation
Resource use in patients with carcinoid syndrome: a retrospective analysis using the French health insurance national (SNDS) database	P11
Progression-Free Survival and Clinical Outcomes with Long-Term Use of Telotristat Ethyl in US Clinical Practice	H21

Follow Ipsen on Twitter via @IpsenGroup and keep up to date with ENETS 2020 Conference news and updates by using the hashtag #ENETS20.

About Ipsen

Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The Group develops and commercializes innovative medicines in three key therapeutic areas – Oncology, Neuroscience and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.5 billion in 2019, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,800 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com .

Forward Looking Statement

The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words "believes", "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2018 Registration Document available on its website (www.ipsen.com ).

References

1. Data on File. ENETS 2020
2. Adelman D et al. Adv Ther 2020 Mar 11. doi:10.1007/s12325-020-01255-8 [Epub ahead of print]
3. Dasari AC et al. JAMA Oncol 2017;3:1335–422.
4. Hallet JC et al. Cancer 2015;121:589–97
5. Brue F et al. OrphanetJ Rare Dis 2016;11:135–52

View source version on businesswire.com: https://www.businesswire.com/news/home/20200310005558/en/